Bausch + Lomb SE5423WVBRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10757770059932), received between Jul 5, 2022 and May 5, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Failure to Cut

  THE USER FACILITY IN ITALY REPORTED THE VITRECTOR WAS ASPIRATING BUT WAS UNABLE TO CUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25081455 ↗
• InjuryJan 27, 2026Failure to Cut; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A USER FACILITY IN SPAIN THAT THE VITREOUS WAS RUPTURED IN THE OPERATING ROOM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Vitreous Loss

  MAUDE report 24193043 ↗
• MalfunctionMay 12, 2025Failure to Cut; Failure to Cut

  A USER FACILITY IN CHINA WAS USING THE VITRECTOMY CUTTER WHICH WAS RATTLING AND NOT CUTTING BUT CONTINUED TO ASPIRATE. THERE WAS PATIENT CONTACT BUT NO EFFECT THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22003998 ↗
• MalfunctionApr 23, 2025Failure to Cut; Failure to Cut

  THE USER FACILITY REPORTED THAT DURING SURGERY THE VITRECTOMY CUTTER WAS FOUND TO HAVE A STRANGE NOISE AND WAS NOT CUTTING. ASPIRATION CONTINUED AFTER IT STOPPED CUTTING. THE SURGERY WAS EXTENDED, BUT THE DELAY TIME WAS NOT PROVIDED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21893790 ↗
• MalfunctionJul 16, 2024Particulates; Particulates

  A USER FACILITY REPORTED THAT A PIECE OF METAL WAS FOUND IN THE PATIENTS EYE AFTER SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19753555 ↗
• InjuryJul 5, 2022Fluid/Blood Leak; Product Quality Problem; Fluid/Blood Leak; Product Quality Problem

  THE USER FACILITY IN (B)(6) REPORTED THE VALVES ON THE TROCARS DID NOT CLOSE PROPERLY. WHEN THE INSTRUMENT WAS REMOVED, THE TROCARS ALSO CAME OUT AND HAD TO BE PLACED AGAIN. THIS OCCURRED ON THREE OCCASIONS FOR THE SAME SURGERY. SERUM ALSO LEAKED THROUGH THE VALVES. THE SURGERIES WERE PROLONGED FOR APPROXIMATELY 15 MINUTES AND SUTURES WERE NOT NECESSARY FOR ALL SURGERIES BUT WERE FREQUENTLY USED. ALL SURGERIES WERE COMPLETED SUCCESSFULLY WITH NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14915791 ↗